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[Posted 04/24/2020]
Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems (1)
AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional
ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA). These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening.
We have reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death. We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available.
BACKGROUND: Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
Hydroxychloroquine and chloroquine:
• should be used for COVID-19 only when patients can be appropriately monitored in the hospital as required by the EUA or are enrolled in a clinical trial with appropriate screening and monitoring. FDA is reviewing the safety of their use when used outside of the setting of hospitalized patients for whom use was authorized.
• have not been shown to be safe and effective for treating or preventing COVID-19.
Hydroxychloroquine和chloroquine經美國FDA核准可治療或預防瘧疾。Hydroxychloroquine尚取得美國FDA核准治療自體免疫疾病，例如慢性盤狀紅斑狼瘡，成人全身性紅斑狼瘡和類風濕性關節炎。然而Hydroxychloroquine和chloroquine有許多副作用，包括嚴重可能危及生命的心律不整問題。美國FDA擔心此類藥品被不適當地用於治療非住院病人的冠狀病毒疾病（COVID-19）或預防該疾病，因此若沒有臨床試驗進行或不符合臨床試驗之條件，美國FDA會通過緊急使用授權（Emergency Use Authorization, EUA），僅供住院的COVID-19患者臨時使用。
美國FDA已審視不良事件通報系統之資料庫、已發表的醫學文獻及美國毒物控制中心國家毒物數據系統中的有關COVID-19病人使用hydroxychloroquine及chloroquine單用或併用azithromycin或其他可能造成 QT延長的藥物出現嚴重心臟相關不良反應以及死亡之報告，這些不良反應包括QT interval延長、心室心搏過速和心室顫動，在某些案例還包含死亡。美國FDA將繼續調查COVID-19病人相關用藥之安全風險，如有更多資訊時會再公開周知。
Hydroxychloroquine和chloroquine之建議：
• 當可依照EUA要求，病人在醫院可被適當監測或參與臨床試驗有適當的篩檢和監測，COVID-19病人才可使用此類藥品。美國FDA對已獲授權使用此類藥品且為住院以外之病人之安全性進行審查。
• 此類藥品之使用尚未證實可安全且有效治療及預防COVID-19。
（待續）
更多相關訊息與連結請參考FDA網址：https://reurl.cc/ZOMYLA
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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